Trial document




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  DRKS00005241

Trial Description

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Title

Effects of hypoxia-supported endurance training on Pulmonary and Cardiovascular Parameters in Patients older than 65.

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Trial Acronym

EHAK-65

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The goal of the study “Effects of hypoxia-supported endurance training on Pulmonary and Cardiovascular Parameters in Patients older than 65.” is to prove, that aerobic training in heights has more positive effects on the heart and lung than training in normal heights.
Endurance in elderly is often reduced, but good aerobic exercise training is sometimes necessary and has great effect on some illnesses. For example high blood pressure, diabetes and it prevents lung, heart and Blood flow problems. For some illnesses sports is the best therapy method and can reduce the need of medicine or make it even obsolete. Old people are often not capable to do proper aerobic training because of orthopedical injuries. In high altitude the Workload for the patients will be reduced while having similar effects on the body.
In this study we will give these Patients the possibility to do aerobic exercise training anyway. To achieve this goal we will provide training sessions in our therapy room. Our system to simulate high altitudes allows us to
Lower the oxygen concentration to 14.2% (See level 21%). This means the room climate will be equivalent to 3000m over sea level. The air pressure won’t be affected. Consecutively our patients will train 7 exercise units of maximal 30 Minutes in our altitude laboratory (only patients from the Ghersburgklinik are allowed to participate). For this training patients can choose between bike and treadmill. We hope to prove that training on 3000m has better effects than training in normal height. The training will be monitored by a sports scientist. During the training we will measure oxigensaturation via pulsoximetry and heart rate via pulsbelt. One Group will train at 3000m and one Group on 600m sham hypoxia, determined by chance. This will allow us to evaluate the differences.
Before and after the exercise period Patients will perform a test on a bike (8-12min), to determine their physical fitness. We will check the heart parameters and function as well, via Echokardiography. In these tests our sports scientist will measure the breathing air and the ECG.
Should we be able to see positive effects of this training it could be a big improvement for geriatric rehabilitation. Altitude training could be an important part in rehabilitation in the future Maybe our results will allow us to give instructions for easy hiking tours for old people even if they suffer from heart diseases.

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Brief Summary in Scientific Language


Because of the development of our society geriatric rehabilitation gains more and more importance for public healthcare. The aim for rehabilitation is to keep old people as mobile and active as possible in order to prevent long stationary stays in hospitals and need of care. Unfortunately for geriatric rehabilitation there are often missing adequate methods or data to refer to. The study Effect of endurance training under hypoxic condition on Pulmonary and Cardiovascular Parameters in Elderly Inpatient Population will try to determine if training in an altitude of 3000m has effects for elderly Patients with cardiopulmonal diseases. In the rehabilitation of old Patients with several diseases there is often a missrelation between training capacity and suitable workload for training, a circumstance that produces bad rehab-output and disaffection in patients and therapists. Because of our experience with mountaineers and high altitude training and because of the positive effects of well dosed hypoxia on the cardiopulmonary system we are wondering if geriatric patients could benefit from altitude training. In hypoxia the demands of the cardiopulmonal system are higher than in normal heights. The heart rate is elevated and the hypoxia induced factor is causing adaptions on several points in the human body. These effects suggest that when the demands of the cardiopumonal system stay the same the workload (in watt) for our patients should be reduced while training in hypoxic air. Because of the reduced mobility and other restrictions old Patients have often problems to train with adequate heart rates for aerobic endurance training. Resuming these observations we want to investigate these effects with a group of 40 Patients of the Ghersburg geriatric clinic for rehabilitation. They will train for three weeks (standard duration for rehabilitation) each second day on a simulated height of 3000m in our hypoxia laboratory (normoxic hypoxia) on a treadmill. Each training unit will last from 10 to 30 minutes (normal duration for endurance training in geriatric rehabilitation). The results will be compared with a control group of 40 Patients who will perform the same training in normoxia. As pre- and posttest we will perform a Siroergometrical test as well as a cardiography. We hope to find significant differences between test and control group. Above all the maximal realizable power (Vo2peak) should be higher than in the group training in sham hypoxia. These findings would mean a much higher realizable activity of daily living for our patients and prove the benefits of the use of altitude training in geriatric rehabilitation. This kind of training could hold a lot of potential for therapy and above all for the Patients.

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Organizational Data

  •   DRKS00005241
  •   2013/09/02
  •   [---]*
  •   yes
  •   Approved
  •   359/12, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1146-8756 
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Health Condition or Problem studied

  •   Cardipulmonal Rehabilitation with geriatric patients.
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Interventions/Observational Groups

  •   Preparation:
    -Consultation of the medical report after accommodation
    -decision of participation
    -education of the patient and signing of the written consent under supervision of a medical doctor.

    Pretest:
    -Collecting of personal data (Weight and height)
    -Echocardiography and comparison with the medical report
    -Ergospirometry (Bike ergometer)
    - decision of participation
    -definition of the training pulse

    Intervention:
    -7 Trainings on 3000m normobaric Hypoxia each second day (preferring treadmill 10-30min)
    -Measurement: Blood pressure, oxygen saturation, pulse
    -Constant updates from the treating physician about acute events or changes in (eventually exclusion)

    Posttest:
    - Collecting of personal data (Weight and height)
    - Echocardiography and comparison with the pretest
    - Ergospirometry (Bike ergometer)
    -Release of the patient with information about his individual parameters
  •   Preparation:
    -Consultation of the medical report after accommodation
    -decision of participation
    -education of the patient and signing of the written consent under supervision of a medical doctor.

    Pretest:
    -Collecting of personal data (Weight and height)
    -Echocardiography and comparison with the medical report
    -Ergospirometry (Bike ergometer)
    - decision of participation
    -definition of the training pulse

    Intervention:
    -7 Trainings on normal height (600m) each second day (preferring treadmill 10-30min)
    -Measurement: Blood pressure, oxygen saturation, pulse
    -Constant updates from the treating physician about acute events or changes in (eventually exclusion)

    Posttest:
    - Collecting of personal data (Weight and height)
    - Echocardiography and comparison with the pretest
    - Ergospirometry (Bike ergometer)
    -Release of the patient with information about his individual parameters
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The data will be collected at the first day of accomodation in the Hospital via Ergospirometry and Echokardiography. Then each Patient will have to perform 7 trainings each second day. The final test will be after 3 weeks via Ergospirometry and Echokardiography.

Main Parameter: Vo2peak

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Secondary Outcome

Pretest at first day of accomodation:

Ecg,
Workload,
Weight,
Bloodpreasure,
Vo2 max,
oxigensaturation,
Puls,
Diagnosis

Posttest after 3 Weeks:

Ecg,
Workload,
Weight,
Bloodpreasure,
Vo2 max,
oxigensaturation,
Puls,
Diagnosis

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/11/01
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

•Age > 65;
•Willingness to participate with written consent.
•Sufficient peripheral blood flow to deliver a pulseoximetry signal.
•Physical and mental capability to perform an Ergospirometry test. (Minimum : 25Watt for 8 minutes)
•Minimum Heart Rate and systolic blood pressure adaption of 20% of the resting pulse.

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Exclusion Criteria

•Final (palliative) status of any disease.
•High risk for Cardiac events or Stroke
•Cognitive Impairment
•Insufficient peripheral blood flow for a reasonable pulseoximetry signal.
•Unwillingness to sign the written consent.
•Incapability to perform an Ergospirometry test.
•Such high dosage of heart and blood circuit medication (ß-Blocker, Amyodaron) that the minimum requirements of adaption to physical stress and hypoxia are not fulfilled. (See above and Pretest)
•Patients with a cardiac impairment equivalent to NYHA IV

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität Ulm. Hermann Buhl Institut für Hypoxie- und Schlafmedizinforschung
    • Mr.  PD Dr. med.  Nikolaus  Netzer 
    • Ghersburgstr. 9
    • 83043  Bad Aibling
    • Germany
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    • Universität Ulm. Hermann Buhl Institut für Hypoxie- und Schlafmedizinforschung
    • Mr.  Stephan  Pramsohler 
    • Ghersburgstr. 9
    • 83043  Bad Aibling
    • Germany
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    • Universität Ulm. Hermann Buhl Institut für Hypoxie- und Schlafmedizinforschung
    • Mr.  Stephan  Pramsohler 
    • Ghersburgstr. 9
    • 83043  Bad Aibling
    • Germany
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Sources of Monetary or Material Support

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    • Universität Ulm. Hermann Buhl Institut für Hypoxie- und Schlafmedizinforschung
    • Mr.  PD Dr. med.  Nikolaus  Netzer 
    • Ghersburgstr. 9
    • 83043  Bad Aibling
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/07/25
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.